1. Technical Field
The present disclosure relates to medical equipment. In particular, the present disclosure relates to an ECG lead system including an ECG lead set, an adapter system, an extension cable and methods for coupling the ECG lead set with an incompatible ECG device that may monitor or record ECG signals, e.g., an “ECG monitor” or “ECG telemetry.”
2. Background of Related Art
Electrocardiograph (ECG) lead systems are widely used to obtain biopotential signals containing information indicative of the electrical activity associated with the heart and pulmonary system. To obtain biopotential signals ECG electrodes are applied to the skin of a patient in various locations and coupled to an ECG device, e.g., an “ECG monitor” or “ECG telemetry.” Placement of the electrodes is dependant on the information sought by the clinician.
The placement of the ECG electrodes on the patient has been established by medical protocols. The most common protocols require the placement of the electrodes in a 3-lead, a 5-lead or a 12-lead configuration. A 3-lead configuration requires the placement of three electrodes; one electrode adjacent each clavicle bone on the upper chest and a third electrode adjacent the patient's lower left abdomen. A 5-lead configuration requires the placement of the three electrodes in the 3-lead configuration with the addition of a fourth electrode adjacent the sternum and a fifth electrode on the patient's lower right abdomen. A 12-lead configuration requires the placement of 10 electrodes on the patient's body. Four electrodes, which represent the patient's limbs, include the left arm electrode (LA lead), the right arm electrode (RA lead), the left leg electrode (LL lead), and the right leg electrode (RL lead). Six chest electrodes (V1-V6 leads) are placed on the patient's chest at various locations near the heart. Three standard limb leads are constructed from measurements between the right arm and left arm (Lead I), the right arm and the left leg (Lead II) and the left arm to left leg (Lead III).
Electrodes, after placement on the patient, connect to an ECG device by an ECG lead set. One end of the ECG lead set, closest to the patient, connects to each electrode (alternatively, the electrodes may be integrated into the distal end of the ECG lead set) and receives biopotential signals from the body. The other end of the ECG lead set connects to the ECG input connector and supplies the biopotential signals received from the body to the ECG device.
ECG devices and ECG lead sets are manufactured and sold by various companies. Although protocols have been established for the placement ECG electrodes, the various manufacturers typically use product specific connectors and wiring configurations.
Problems occur when an ECG lead set and an ECG monitor are electrically incompatible but have mechanically compatible connectors. While some problems may be automatically detected by the ECG device, other problems, such as, for example, the incorrect order of V1-V6, may go undetected and the ECG device may provide the clinician with erroneous information.
Some ECG devices are configured to connect to a specific type or family of ECG lead sets manufactured, distributed and sold by the same manufacturer of the ECG device. The ECG device, and specific type or family of ECG lead sets, may utilize, as a safety feature, a unique or specialized connector that is only compatible with the particular ECG device and incompatible with all other ECG lead sets.
While this safety feature may prevent a clinician from accidentally connecting an incompatible lead set to an ECG device, it also requires each medical facility to supply a plurality of ECG lead sets for the various ECG device used within a medical facility.
Additionally, in many instances, a patient may require one type of ECG lead system while in, for example, the emergency room (ER), the operating room (OR), the post-anesthesia care unit (PACU), the intensive care unit (ICU) and/or the critical care unit (CCU); and may require a second or different type ECG lead system while on, for example, a telemetry floor. In particular, a patient may require a relatively longer ECG lead set in order to connect to an ECG monitor while the patient is in the ER, the OR, the PACU, the ICU and/or the CCU; and a relatively shorter ECG lead set in order to connect to an ECG telemetry while the patient is on a telemetry floor.
Accordingly, a need exists for a system that will enable an end user to use a single ECG lead set across various ECG device platforms and to accommodate the use of the ECG lead set with either an ECG monitor and/or ECG telemetry as needed and7/or desired.
The present application provides an ECG lead set, adapter system and methods for coupling a standard ECG lead set with any incompatible ECG device thus preventing the aforementioned concerns.